Open clinical trial addressing the effect of a nutritional support based on whey proteins, leucine and vitamin D on muscle mass and multiple anticancer treatment-related endpoints in patients with gynecologic cancer receiving first-line platinum-based chemotherapy (adjuvant or curative). A comparison to matched historical controls will be performed to address potential evidence of efficacy to be investigated in a subsequent randomized trial.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
50
Two servings (40 grams each) of powder (Fortifit®; Nutricia) which has to be dissolved in 125 ml of water. Per serving, 20 g whey protein, 3 g total leucine, 9 g carbohydrates, 3 g fat, 800 IU vitamin D, and a mixture of vitamins, minerals, and fibers.
Control group receiving no nutritional intervention or on-demand non muscle-targeted intervention such as nutritional counseling with or without oral nutritional supplement
IRCCS San Matteo
Pavia, Italy, Italy
RECRUITINGChange in muscle mass area
Change in muscle mass at the end of first-line platinum-based chemotherapy (adjuvant or curative) evaluated with computed tomography scan at the level of the third lumbar vertebra
Time frame: 18 weeks
Skeletal muscle mass
Change in skeletal muscle mass during the study evaluated with bioimpedance vectorial analysis
Time frame: 18 weeks
Body weight
Change in body weight during the study (assessed at each chemotherapy cycle)
Time frame: 18 weeks
Protein-calorie intake
Change in protein-calorie intake during the study (assessed at each chemotherapy cycle)
Time frame: 18 weeks
Handgrip strength
Change in handgrip strength
Time frame: 18 weeks
Treatment-related moderate-severe adverse events as assessed by Common Terminology Criteria for Adverse Events [CTCAE v5.0]
Difference in the incidence of grade \>=3 toxicity, according to CTCAE v5.0. Toxicity is graded on 0-5 ordinal scale where a higher score means a worse outcome.
Time frame: 18 weeks
Adherence to treatment schedule
Difference in the proportion of patients completing the treatment schedule as planned
Time frame: 18 weeks
Total dose of chemotherapy administered
To be calculated as the percentage of chemotherapy dose administered with respect to the treatment plan
Time frame: 18 weeks
Patients requiring unplanned hospitalization
The rate of patients requiring unplanned hospitalization (one or more) during the study will be calculated
Time frame: 18 weeks
Tolerance to nutritional support
Occurrence of events of gastrointestinal intolerance
Time frame: 18 weeks
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